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NCT02431247 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed Dose Combination (FDC) Versus a Regimen Consisting of Darunavir/Cobicistat FDC With Emtricitabine/Tenofovir Disoproxil Fumarate FDC in Treatment-naive HIV Type 1 Infected Subjects

A Phase 3 study, sponsored by Janssen Sciences Ireland UC.

Completed
Registry status
Phase 3
Development phase
725
Enrollment target

NCT02431247 is a Phase 3 study that has completed, run by Janssen Sciences Ireland UC. The registered enrollment target is 725 participants.

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The verdict

NCT02431247, a Phase 3 study, has completed, sponsored by Janssen Sciences Ireland UC.

COMPLETED
Registry status
Phase 3
Development phase
725 participants
Enrollment target

Study Summary

The purpose of this study is to demonstrate non-inferiority in efficacy of a darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus Darunavir/Cobicistat (DRV/COBI) FDC coadministered with Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) FDC in human immunodeficiency virus-1 (HIV-1) infected, antiretroviral (ARV) treatment naive adult participants.

Interventions

  • DRUG DRV/COBI FDC
  • DRUG Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC
  • DRUG FTC/TDF FDC
  • DRUG D/C/F/TAF FDC - Matching Placebo
  • DRUG FTC/TDF FDC Matching Placebo

Trial Details

FieldValue
Enrollment Target 725 participants
Start Date 2015-07-06
Est. Completion 2020-09-30
Phase Phase 3

Sponsor

Janssen Sciences Ireland UC

7 total trials

What the Registry Record Tells You About NCT02431247

The ClinicalTrials.gov registry entry for NCT02431247 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 725 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Sciences Ireland UC, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which DRV/COBI FDC is the first listed.

NCT02431247 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02431247 about?

NCT02431247 is a clinical study titled "A Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed Dose Combination (FDC) Versus a Regimen Consisting of Darunavir/Cobicistat FDC With Emtricitabine/Tenofovir Disoproxil Fumarate FDC in Treatment-naive HIV Type 1 Infected Subjects". The purpose of this study is to demonstrate non-inferiority in efficacy of a darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus Darunavir/Cobicistat (DRV/COBI) FDC coadministered with Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) F...

What is the current status of trial NCT02431247?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 725 participants. The study started on 2015-07-06. Estimated completion is 2020-09-30.

What interventions are being tested in trial NCT02431247?

The interventions under investigation include: DRV/COBI FDC (DRUG), Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC (DRUG), FTC/TDF FDC (DRUG), D/C/F/TAF FDC - Matching Placebo (DRUG), FTC/TDF FDC Matching Placebo (DRUG).

Who is sponsoring clinical trial NCT02431247?

This trial is sponsored by Janssen Sciences Ireland UC, which has 7 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.